Risk of hypoglycemia is increased when GLYXAMBI is combined with insulin. May require lower insulin dosages.
Source: NLP:empagliflozin and linagliptin
Empagliflozin And Linagliptin Interactions
Brand names: Glyxambi
Dipeptidyl Peptidase 4 Inhibitor · Sodium-Glucose Cotransporter 2 Inhibitor · Dipeptidyl Peptidase 4 Inhibitors · Sodium-Glucose Transporter 2 Inhibitors
Route: Oral
Contraindications
4 CONTRAINDICATIONS GLYXAMBI is contraindicated in patients: with a hypersensitivity to empagliflozin, linagliptin, or any of the excipients in GLYXAMBI, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred [see Warnings and Precautions (5.7) and Adverse Reactions (6) ] . Hypersensitivity to empagliflozin, linagliptin, or any of the excipients in GLYXAMBI. ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary Based on animal data showing adverse renal effects from empagliflozin, GLYXAMBI is not recommended during the second and third trimesters of pregnancy. The limited available data with GLYXAMBI, linagliptin, or empagliflozin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations ). In animal studies, empagliflozin, a component of GLYXAMBI, resulted in adverse renal changes in rats when administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. Doses approximately 13-times the maximum clinical dose caused renal pelvic and tubule dilatations that were reversible. No adverse developmental effects were observed when the combination of linagliptin and empagliflozin was administered to pregnant rats (see Data ). The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20% to 25% in women with HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Animal Data The combined components administered during the period of organogenesis were not teratogenic in rats up to and including a combined dose of 700 mg/kg/d
5 interactions on record
Strong P-gp or CYP3A4 inducer decreases linagliptin exposure and may reduce efficacy. Alternative treatments strongly recommended.
Source: NLP:empagliflozin and linagliptin
Risk of hypoglycemia is increased when GLYXAMBI is combined with sulfonylureas (insulin secretagogues). May require lower dosages.
Source: NLP:empagliflozin and linagliptin
Coadministration with empagliflozin increases urine volume and frequency, enhancing potential for volume depletion. Monitor volume status and renal function.
Source: NLP:empagliflozin and linagliptin
SGLT2 inhibitor component may decrease serum lithium concentrations. Monitor lithium levels more frequently during initiation and dosage changes.
Source: NLP:empagliflozin and linagliptin